Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction, 17859-17860 [2014-06994]

Download as PDF Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Rules and Regulations (2) Pratt & Whitney Engine Manual, P/N 1A6231, (PW2000) and P/N 1B2412 (F117), Chapter 72–41–00, Inspection/Check-02, (Task 72–41–00–230–002) and Chapter 72– 52–00, Inspection/Check-02 (Task 72–52–00– 230–000), which are not incorporated by reference in this AD, can be obtained from Pratt & Whitney, using the contact information in paragraph (l)(3) of this AD. (l) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Pratt & Whitney Service Bulletin No. PW2000 72–763, Revision 1, dated August 30, 2013. (ii) Reserved (3) For PW service information identified in this AD, contact Pratt & Whitney, 400 Main St., East Hartford, CT 06108; phone: 860–565–8770; fax: 860–565–4503. (4) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125. (5) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued in Burlington, Massachusetts, on March 6, 2014. Colleen M. D’Alessandro, Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft Certification Service. [FR Doc. 2014–06953 Filed 3–28–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA–2013–0079; Airspace Docket No. 09–AWA–4] RIN 2120–AA66 Amendment to Class B Airspace Area; Detroit, MI Federal Aviation Administration (FAA), DOT. ACTION: Final rule; correction. emcdonald on DSK67QTVN1PROD with RULES AGENCY: This action corrects a final rule published in the Federal Register January 21, 2014. In that rule, the shared boundary between the Detroit Class B airspace Area A and Area B subareas did not match, as originally intended, in the regulatory text descriptions. This SUMMARY: VerDate Mar<15>2010 16:18 Mar 28, 2014 Jkt 232001 correction is necessary to close the unintended gap between subareas created by the boundary error and to ensure the accuracy of the charted Detroit Class B airspace area. DATES: Effective Date: 0901 UTC, April 3, 2014. The Director of the Federal Register approves this incorporation by reference action under 3 CFR part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy and Regulations Group, Office of Airspace Services, Mission Support, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267–8783. SUPPLEMENTARY INFORMATION: History Correction to Final Rule Accordingly, pursuant to the authority delegated to me, in the Federal Register of January 21, 2014, the text on page 3312, column 2, line 47, is corrected to read: Frm 00011 [Amended] AGL MI B Detroit, MI [Corrected] For Area A, between the words ‘‘Airport;’’ and ‘‘thence’’, add the following: ‘‘thence northeast to the intersection of the DXO VOR/DME 354° radial and the Detroit Willow Run Airport 047° bearing:’’. Issued in Washington, DC, on March 24, 2014. Ellen Crum, Acting Manager, Airspace Policy and Regulations Group. [FR Doc. 2014–06959 Filed 3–28–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 On January 21, 2014, a final rule for FAA Docket No. FAA–2012–0661, Airspace Docket No. 09–AWA–4, was published in the Federal Register (79 FR 3305) to amend the Detroit Class B airspace area. The Detroit Class B airspace area was modified to contain aircraft conducting published instrument procedures at Detroit Metropolitan Wayne County Airport (DTW) within Class B airspace, enhance safety, improve the flow of air traffic, and reduce the potential for midair collisions in the DTW terminal area, while accommodating the concerns of all airspace users. Subsequent to publication of the rule, the FAA determined the boundary segment described in Area A, from lat. 42°17′18″ N., long. 83°27′27″ W. on the 4.4-mile radius of the Detroit Willow Run Airport to lat. 42°20′47″ N., long. 83°22′12″ W. on the 8-mile arc of the DXO VOR/DME, and the boundary segment described in Area B, from the intersection of the DXO VOR/DME 354° radial and the Detroit Willow Run Airport 047° bearing to lat. 42°20′47″ N., long. 83°22′12″ W., did not align as intended and contained a gap between the two adjacent subareas. The FAA is correcting this minor error by adding the geographic point defined by the intersection of the DXO VOR/DME 354° radial and the Detroit Willow Run Airport 047° bearing in the Area A description to remove the gap. PO 00000 § 71.1 17859 Fmt 4700 Sfmt 4700 [Docket No. FDA–2014–N–0002] Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction AGENCY: Food and Drug Administration, HHS. Final rule; correcting amendments. ACTION: The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect the withdrawal of approval of new animal drug applications (NADAs) that appeared in the Federal Register of February 27, 2014 (79 FR 10976). That document listed an NADA for which a withdrawal of approval (WOA) was not intended and failed to remove all conditions of use associated with the withdrawn NADAs. This correction is being made to improve the accuracy of the animal drug regulations. DATES: This correction is effective March 31, 2014. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is correcting a document amending the animal drug regulations to reflect the WOA of NADAs that appeared in the Federal Register of February 27, 2014 (79 FR 10976). That document listed an NADA for which a WOA was not intended and failed to remove all SUMMARY: E:\FR\FM\31MRR1.SGM 31MRR1 17860 Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Rules and Regulations conditions of use associated with the withdrawn NADAs. This correction is being made to improve the accuracy of the animal drug regulations. In the preamble in rule FR Doc. 2014– 02617 published on February 27, 2014 (79 FR 10976), make the following corrections: On page 10976, in the second column, in the 4th line of the ‘‘SUMMARY’’ section, remove ‘‘69’’ and replace with ‘‘68’’. On page 10977, appearing near the end of the page, ‘‘Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 16 NADAs and 8 ANADAs’’, is corrected to read ‘‘Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 15 NADAs and 8 ANADAs’’; and on the same page in the table, the entry ‘‘013– 461 3–NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).’’ is removed. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801– 808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is corrected by making the following correcting amendments. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. § 558.195 [Amended] 2. In § 558.195, remove paragraph (e)(1)(vii). ■ § 558.355 [Amended] 3. In § 558.355, remove and reserve paragraph (b)(3). ■ 4. In § 558.635, revise paragraphs (d)(4)(v), (d)(4)(vi), and (d)(4)(vii) to read as follows: emcdonald on DSK67QTVN1PROD with RULES ■ § 558.635 * Virginiamycin. * * * * (d) * * * (4) * * * (v) Monensin as in § 558.355. (vi) Salinomycin as in § 558.550. (vii) Semduramicin as in § 558.555. VerDate Mar<15>2010 16:18 Mar 28, 2014 Jkt 232001 Dated: March 25, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014–06994 Filed 3–28–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 31 [TD 9662] RIN 1545–BJ31 Designation of Payor To Perform Acts Required of an Employer Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. AGENCY: This document contains final regulations under section 3504 of the Internal Revenue Code (Code) providing circumstances under which a person (payor) is designated to perform the acts required of an employer and is liable for employment taxes with respect to wages or compensation paid by the payor to individuals performing services for the payor’s client pursuant to a service agreement between the payor and the client. SUMMARY: Effective date: These final regulations are effective on March 31, 2014. Applicability date: For dates of applicability, see § 31.3504–2(f) of these regulations. FOR FURTHER INFORMATION CONTACT: Jeanne Royal Singley at (202) 317–6798 (not a toll-free number). SUPPLEMENTARY INFORMATION: DATES: Background This document contains amendments to 26 CFR part 31 under section 3504 of the Code. On January 29, 2013, Treasury and the IRS published a notice of proposed rulemaking (REG–102966–10, 78 FR 6056) (the proposed regulations) in the Federal Register under section 3504 of the Code. Treasury and the IRS received written and electronic comments responding to the proposed regulations. All comments were considered and are available for public inspection at https:// www.regulations.gov or upon request. After consideration of all the public comments, the proposed regulations are adopted as amended by this Treasury decision. The public comments and revisions are discussed in this preamble. PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 Explanation of Provisions Under section 3504, if a payor pays wages or compensation to employees who are employed by one or more employers, the Secretary is authorized, in accordance with regulations prescribed by the Secretary, to designate such payor to perform acts required of employers under the Code. Section 3504 further provides that, except as otherwise prescribed by the Secretary, all provisions of law (including penalties) applicable with respect to an employer are applicable to the payor so designated, but the employer for whom the payor acts remains subject to the provisions of law (including penalties) applicable with respect to employers. Accordingly, both an employer and the payor designated in accordance with regulations under section 3504 are liable for the employment taxes on wages or compensation paid by the payor. The IRS has established administrative procedures under which a payor may request authorization on Form 2678, Employer/Payer Appointment of Agent, to file employment tax returns and perform other acts for the employer. The proposed regulations provide rules regarding the employment tax obligations under certain three-party arrangements in which a payor enters into an agreement with the employer (client) to perform the employment tax obligations of the client with regard to wages or compensation paid by the payor to individuals performing services for the client, but the payor does not use the established IRS administrative procedures to request authorization to file employment tax returns and performs other acts for the client. Under the proposed regulations, a payor is designated under section 3504 to perform the acts of an employer in any case in which the payor enters into a service agreement with a client. For this purpose, the term service agreement means a written or oral agreement pursuant to which the payor (1) asserts it is the employer (or ‘‘co-employer’’) of individuals performing services for the client, (2) pays wages or compensation to the individuals for services the individuals perform for the client, and (3) assumes responsibility to collect, report, and pay, or assumes liability for, any employment taxes with respect to the wages or compensation paid by the payor to the individuals who perform services for the client. The proposed regulations also provide exceptions to when a payor is designated under section 3504 to perform the acts of an employer even if the payor has entered into an agreement E:\FR\FM\31MRR1.SGM 31MRR1

Agencies

[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Rules and Regulations]
[Pages 17859-17860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]


Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug 
Applications for Combination Drug Medicated Feeds Containing an 
Arsenical Drug; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document amending the animal drug regulations to reflect the withdrawal 
of approval of new animal drug applications (NADAs) that appeared in 
the Federal Register of February 27, 2014 (79 FR 10976). That document 
listed an NADA for which a withdrawal of approval (WOA) was not 
intended and failed to remove all conditions of use associated with the 
withdrawn NADAs. This correction is being made to improve the accuracy 
of the animal drug regulations.

DATES: This correction is effective March 31, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is correcting a document amending the 
animal drug regulations to reflect the WOA of NADAs that appeared in 
the Federal Register of February 27, 2014 (79 FR 10976). That document 
listed an NADA for which a WOA was not intended and failed to remove 
all

[[Page 17860]]

conditions of use associated with the withdrawn NADAs. This correction 
is being made to improve the accuracy of the animal drug regulations.
    In the preamble in rule FR Doc. 2014-02617 published on February 
27, 2014 (79 FR 10976), make the following corrections:
    On page 10976, in the second column, in the 4th line of the 
``SUMMARY'' section, remove ``69'' and replace with ``68''.
    On page 10977, appearing near the end of the page, ``Huvepharma AD, 
5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested 
that FDA withdraw approval of the following 16 NADAs and 8 ANADAs'', is 
corrected to read ``Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 
1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the 
following 15 NADAs and 8 ANADAs''; and on the same page in the table, 
the entry ``013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and 
ethopabate).'' is removed. This rule does not meet the definition of 
``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular 
applicability.'' Therefore, it is not subject to the congressional 
review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
corrected by making the following correcting amendments.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.195  [Amended]

0
2. In Sec.  558.195, remove paragraph (e)(1)(vii).


Sec.  558.355  [Amended]

0
3. In Sec.  558.355, remove and reserve paragraph (b)(3).

0
4. In Sec.  558.635, revise paragraphs (d)(4)(v), (d)(4)(vi), and 
(d)(4)(vii) to read as follows:


Sec.  558.635  Virginiamycin.

* * * * *
    (d) * * *
    (4) * * *
    (v) Monensin as in Sec.  558.355.
    (vi) Salinomycin as in Sec.  558.550.
    (vii) Semduramicin as in Sec.  558.555.

    Dated: March 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-06994 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P
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